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更多关于美国 FDA 21 CFR 第 73 部分的内容，请详见美国FDA 21 CFR 第73部分关于免除产品证书的食品用着色剂种类汇总
§ 73.100 Cochineal extract; carmine.
（a） Identity. （1） The color additive cochineal extract is the concentrated solution obtained after removing the alcohol from an aqueous-alcoholic extract of cochineal （ Dactylopius coccus costa （ Coccus cacti L.））. The coloring principle is chiefly carminic acid.
（2） The color additive carmine is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles, chiefly carminic acid, obtained by an aqueous extraction of cochineal （ Dactylopius coccus costa （ Coccus cacti L.））.
（3） Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
（b） Specifications. （1） Cochineal extract shall conform to the following specifications:
pH, not less than 5.0 and not more than 5.5 at 25 °C.
Protein （N × 6.25）, not more than 2.2 percent.
Total solids, not less than 5.7 and not more than 6.3 percent.
Methyl alcohol, not more than 150 parts per million.
Lead （as Pb）, not more than 10 parts per million.
Arsenic （as As）, not more than 1 part per million.
Carminic acid, not less than 1.8 percent.
（2） Carmine shall conform to the following specifications:
Volatile matter （at 135 °C. for 3 hours）, not more than 20.0 percent.
Ash, not more than 12.0 percent.
Lead （as Pb）, not more than 10 parts per million.
Arsenic （as As）, not more than 1 part per million.
Carminic acid, not less than 50.0 percent.
Carmine and cochineal extract shall be pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances （other than chemical preservatives） that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable substances are those substances that perform a useful function in the pasteurization or other treatment to render the carmine and cochineal extract free of viable Salmonella microorganisms, which substances are not food additives as defined in section 201（s） of the act or, if they are food additives as so defined, are used in conformity with regulations established pursuant to section 409 of the act.
（c） Uses and restrictions. Carmine and cochineal extract may be safely used for coloring foods generally in amounts consistent with good manufacturing practice, except that they may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
（d） Labeling requirements . （1） The label of the color additives and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of §70.25 of this chapter.
（2） The label of food products intended for human use, including butter, cheese, and ice cream, that contain cochineal extract or carmine shall specifically declare the presence of the color additive by listing its respective common or usual name, “cochineal extract” or “carmine,” in the statement of ingredients in accordance with §101.4 of this chapter.
（e） Exemption from certification. Certification of these color additives is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721（c） of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 74 FR 216, Jan 5, 2009]
§73.100 胭脂虫提取物；胭脂红
（a）特性：
（1）着色剂胭脂虫提取物，系用含水醇提取胭脂虫（Dactylopius coccus costa;Coccus cacti L.），然后除去醇后所得的浓缩液，其着色物质主要是胭脂红酸。
（2）着色剂胭脂红，系胭脂虫经水提取后所得的以胭脂红酸为主要着色物质的基料，经氢氧化铝处理而成的铝或钙铝色淀。
（3）用胭脂虫提取物或由胭脂红配制成的食用着色剂混合物，只能选用合适的本分部所列的可安全地用于食品着色的着色剂混合物稀释剂。
（b）质量规格：
（1）胭脂虫提取物应符合下列质量指标：
pH，在25℃时，为5.0～5.5。
蛋白质（N×6.25），不超过2.2%。
总固体，5.7%～6.3%。
甲醇，不超过150mL/kg。
铅（以Pb计），不超过10mg/kg。
砷（以As计），不超过1mg/kg。
胭脂红酸，不低于1.8%。
（2）胭脂红应符合下列质量指标：
挥发物（135℃，3h），不超过20.0%。
灰分，不超过12.0%。
铅（以Pb计），不超过10mg/kg。
砷（以As计），不超过1mg/kg。
胭脂红酸，不低于50.0%。
胭脂红和胭脂虫提取物均需经巴氏灭菌或类似处理，以杀灭所有活的沙门氏菌，在巴氏灭菌或类似的处理中，可加入安全且合适的物质（不包括化学防腐剂）。作为巴氏灭菌或其它处理方法也不可少的物质，它们在巴氏灭菌或其它处理中的功能，是使胭脂红或胭脂虫提取物中不存在活的沙门氏菌，这些物质不属于法规§201（S）中的食品添加剂，或者，如果它们在该法规中属于食品添加剂，但其用量应符合法规§409中的规定。
（c）使用和限制条件：胭脂红和胭脂虫提取物在其用量符合现行GMP用量条件下，可安全地用于一般食品的着色，但不能用于本法规§401所颁布的已确定标准的食品的着色，除非所加入的色素是这类标准所允许的。
（d）标签标注方式：本着色剂和任何由本着色剂所配制成的混合物，拟单独使用或起部分着色效果时，其标签必须符合本章§70.25中的要求。
（e）免除产品证书：本着色剂免除产品证书以保护公众健康。所生产的每批产品也免除按法规721（c）中所规定的需要产品证书。
